FDA Medical Device Approval: Is There a Better Way? (Part 2 of ...

FDA Medical Device Approval: Is There a Better Way? - House Oversight Committee - 2011-06-02 - House Committee on Oversight and Government Reform ...

Sharps Terminator destroys syringe needles immediately after use

20.05.12

A new device that destroys syringe needles immediately after . use, rendering them harmless, has been launched in the UK at the Royal. It is estimated that around 100,000 needlestick injuries occur in. the UK each year, but as many as 60–80% may go unreported, making it. impossible to estimate the true extent of the problem. According to. the Royal College of Nursing (RCN), at least 48% of nurses during. The Sharps Terminator, which destroys the needle shaft in a. single-handed action leaving the user with only the plastic syringe,. Most needlestick injuries occur soon after the needle has been. their working life will have been injured by a needle or sharp that. directly after use, the Sharps Terminator removes the immediate risk. withdrawn from the patient, so by totally eliminating the needle.

Source: MTBeurope

European Union (EU) Medical Device Directive (MDD) Changes ...

by truemarketresearch

In September 2007, a new medical device directive, 2007/47/EC, was approved which sets out to clarify and update the current Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMD). Compliance with requirements of the European Union’s (EU) Medical Device Directive (MDD) is shown by placing the CE marking on the marketed product and supplying the device with a declaration of conformity. Whilst most changes in the new directive are clarifications of existing regulations, there will still be a significant impact on the medical device industry with it. Companies will need to adapt and conform to these new directives before the... European Union (EU) Medical Device Directive (MDD) Changes: Industry Impact Analysis....

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European Union Medical Device Directive - News


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